ACUITY trial - Summary & Results

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A randomized study on acute catheterization and urgent intervention triage strategy (ACUITY) using patients with moderate to high-risk ACS

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ACUITY trial - Summary & Results

  1. 1. ACUITY (Acute Catheterization andUrgent Intervention Triage Strategy)
  2. 2. ACUITY (Acute Catheterization and Urgent InterventionTriage Strategy)GW Stone (Columbia University Medical Center Cardiovascular Research Foundation, NY)American College of Cardiology 2006 Scientific Sessions• Population and treatment: 13 819 patients with moderate- to high-risk ACS who all underwent cardiac catheterization within 72 hours + percutaneous or surgical revascularization when appropriate Patients randomized to: UFH or enoxaparin plus routine GP IIb/IIIa inhibition; bivalirudin plus routine GP IIb/IIIa inhibition; or bivalirudin alone, with GP IIb/IIIa inhibition only given as bailout• Primary outcome: Composite of death, MI, unplanned revascularization for ischemia, and major bleeding at 30 days
  3. 3. ACUITY: Results• Significantly less bleeding than and a similar rate of ischemic events with bivalirudin vs UFH or enoxaparin + a GP IIb/IIIa blocker–a benefit that is lost when bivalirudin is combined with a GP IIb/IIIa blockerPrimary end point at 30 days End point UFH/enoxaparin Bivalirudin alone pa Bivalirudin pb + GP IIb/IIIa (n=4612), % + GP IIb/IIIa blocker blocker (n=4603), % (n=4604), % Non- Superiority Non- Superiority inferiority inferiority Death/MI/unplanned 11.7 10.1 0.0001 0.015 11.8 0.0001 0.93 revascularization/major bleeding Death/MI/unplanned 7.3 7.8 0.011 0.32 7.7 0.07 0.39 revascularization Major bleeding 5.7 3.0 0.0001 0.0001 5.3 0.0001 0.38a. For UFH/enoxaparin + GP IIb/IIIa blocker vs bivalirudin aloneb. For UFH/enoxaparin + GP IIb/IIIa blocker vs bivalirudin + GP IIb/IIIa blocker
  4. 4. ACUITY: Commentary*"This is a very complicated trial . . . To make recommendations on these results,we need to take a detailed look at the data, which has not been possible so far." - Dr Paul Armstrong"The biggest issue for me about this trial is that they used a control group that is ablended mix of therapies. . . . We go to the cath lab fast with [ACS] patients, andyou need at least two doses of enoxaparin to get maximum therapeutic efficacy;there may not be time for that. I want to know how bivalirudin compares withunfractionated heparin without the enoxaparin patients included." - Dr Dan Simon*All comments from ACUITY: Bivalirudin preferential to heparin plus GP IIb/IIIa blocker in ACS patientsheading to the cath lab early (http://www.theheart.org/article/663535.do)
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